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510(k) Data Aggregation
K Number
K181772Device Name
NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
Manufacturer
Date Cleared
2018-08-01
(29 days)
Product Code
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
Ceterix Orthopaedics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NovoStitch Pro Mensical Repair System is intended for approximation of soft tissue in meniscal repair procedures.
Device Description
The NovoStitch Pro Meniscal Repair System, size 0 is a new configuration of the predicate device. While the predicate device passes size 2-0 suture, this new configuration passes size 0 braided, nonabsorbable, surgical suture through soft tissue in arthroscopic surgery. It is comprised of a handheld surgical instrument to which cartridges preloaded with suture are attached.
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K Number
K180531Device Name
NovoStitch Pro Meniscal Repair System
Manufacturer
Date Cleared
2018-03-29
(29 days)
Product Code
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
Ceterix Orthopaedics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NovoStitch Pro Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.
Device Description
The NovoStitch Pro Meniscal Repair System is a next generation of the predicate device, the NovoStitch Plus Meniscal Repair System. The NovoStitch Pro Meniscal Repair System passes size 2-0 braided, nonabsorbable, polyethylene surgical suture through soft tissue in arthroscopic surgery. It is comprised of a handheld surgical instrument to which cartridges preloaded with polyethylene suture are attached.
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K Number
K143356Device Name
NovoStitch Plus Meniscal Repair System
Manufacturer
Date Cleared
2015-07-21
(239 days)
Product Code
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
Ceterix Orthopaedics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NovoStitch Plus Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.
Device Description
The NovoStitch Plus Meniscal Repair System passes size 2-0 braided, non-absorbable, polyethylene surgical suture through soft tissue in arthroscopic surgery. It is comprised of a handheld surgical instrument to which cartridges preloaded with polyethylene suture are attached.
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